American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP InternistWeekly



In the News for the Week of July 15, 2014




Highlights

Nurse-managed protocols associated with modest improvement in control of chronic conditions, analysis finds

Medication titration by nurses according to protocols was associated with a modest improvement in control of chronic diseases in outpatient practice, a recent review and meta-analysis found. More...

Combining smoking cessation therapies improves abstinence rates

Varenicline in combination with nicotine replacement therapy was more effective than varenicline alone in helping smokers quit, a study found. More...


Test yourself

MKSAP Quiz: 5-year history of slowly progressive dysphagia

A 25-year-old man is evaluated for a 5-year history of slowly progressive solid-food dysphagia that is accompanied by a sensation of food sticking in his lower retrosternal area. He has compensated by modifying his diet and avoiding fibrous meats. He has not lost weight, and he has not had trouble drinking liquids. Following a physical exam, what is the most likely diagnosis? More...


Medication adherence

Varying appearance of generic pills may affect medication adherence after MI

Adherence to medications after myocardial infarction (MI) in patients with cardiovascular disease may be affected by variation in pill appearance, according to a new study. More...


Women's health

Selective COX-2 inhibitors associated with slightly increased risk for adverse cardiovascular events in postmenopausal women

Postmenopausal women who used selective COX-2 inhibitors and NSAIDs with more COX-2 than COX-1 inhibition had a modestly increased risk for cardiovascular events, a study concluded. More...


Pulmonology

Early hospital-initiated rehab for chronic respiratory disease shows no benefit versus usual care

Patients hospitalized for chronic respiratory disease did not appear to benefit from early rehab started during their hospital stay versus usual care, according to a new study. More...


Practice management

Physicians and teaching hospitals begin registering in CMS's Open Payments

Physicians and teaching hospitals must register with the Open Payments system if they want the opportunity to review and dispute data submitted by applicable manufacturers and applicable group purchasing organizations (GPOs) prior to public posting on Sept. 30. More...


From the College

Clinicians needed for survey on patient health behaviors

ACP is making available to its members an online survey that is part of research being conducted at Baylor College of Medicine to explore the influence of behavioral counseling used by primary care practitioners with patients exhibiting risky health behaviors. More...


Cartoon caption contest

Vote for your favorite entry

ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner. More...


Physician editor: Daisy Smith, MD, FACP



Highlights


.
Nurse-managed protocols associated with modest improvement in control of chronic conditions, analysis finds

Medication titration by nurses according to protocols was associated with a modest improvement in control of chronic diseases in outpatient practice, a recent review and meta-analysis found.

Researchers reviewed studies of patients with diabetes, hypertension, and hyperlipidemia published between 1980 and 2013 in which registered nurses titrated, or in some cases initiated, medications according to a protocol. They selected 18 studies (11 in Western Europe, 7 in the U.S.) with more than 20,000 patients for inclusion. Results were published in the July 15 Annals of Internal Medicine.

annals.jpg

In a meta-analysis, nurse-managed titration was associated with decreases in HbA1c level (−0.4%; 95% CI, −0.1% to −0.7%), systolic blood pressure (−3.68 mm Hg; 95% CI, −1.05 to −6.31 mm Hg), and diastolic blood pressure (−1.56 mm Hg; 95% CI, −0.36 to −2.76 mm Hg). The analysis also found statistically insignificant drops in cholesterol with protocol care: −0.24 mmol/L (−9.37 mg/dL) in total cholesterol and −0.31 mmol/L (−12.07 mg/dL) in low-density lipoprotein cholesterol.

The results show that the nurse-managed protocols were associated with a consistently positive effect on patient care, the authors concluded, although they noted that only 1 of the included studies reported on adverse effects. The failure of the literature to provide detailed descriptions of the interventions and the fact that most of the studies were conducted outside of the U.S. were other limitations. Still, the meta-analysis indicates that nurses can successfully titrate medications and that such team approaches may improve outcomes for stable, chronically ill patients, the study authors wrote.

Although the meta-analysis was limited and research is needed into the effects on complex or unstable patients, the results suggest that nurse-managed protocols could be part of the solution to the shortage and busyness of primary care physicians, according to an accompanying editorial. "Like it or not, outpatient medicine has become too complicated for physicians to handle by themselves," the editorialists wrote.


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Combining smoking cessation therapies improves abstinence rates

Varenicline in combination with nicotine replacement therapy was more effective than varenicline alone in helping smokers quit, a study found.

Researchers conducted a randomized, blinded, placebo-controlled clinical trial with a 12-week treatment period and 12 weeks of follow-up in 7 centers in South Africa from April 2011 to October 2012. Researchers randomized 446 generally healthy smokers in a 1:1 ratio. Eligible people were adults who sought assistance with smoking cessation, had smoked at least 10 cigarettes a day in the previous year and the month prior to screening, and had had no period of smoking abstinence longer than 3 months in the past year. Nicotine or placebo patch treatment began 2 weeks before the target quit date and continued for 12 weeks. Varenicline was started 1 week before the target quit date, continued for 12 weeks, and tapered off during week 13.

Tobacco abstinence was established and confirmed by exhaled carbon monoxide measurements at the target quit date and at intervals for up to 24 weeks. The primary end point was confirmed continuous abstinence for weeks 9 to 12 of the treatment. Secondary end points included point prevalence abstinence at 6 months, continuous abstinence rate from weeks 9 through 24, and adverse events.

Results appeared July 9 in the Journal of the American Medical Association.

Participants who received varenicline and active nicotine replacement therapy were more likely to achieve continuous abstinence at 12 weeks (55.4% vs 40.9%; P=0.007) and 24 weeks (49.0% vs 32.6%; P=0.004) and point prevalence abstinence at 24 weeks (65.1% vs 46.7%; P=0.002) than those receiving varenicline and placebo. The numbers needed to treat (NNT) to achieve 1 additional successful attempt at smoking cessation were 7 (95% CI, 5 to 20) for nicotine replacement therapy and 7 (95% CI, 4 to 14) for varenicline alone.

The mean weight gain in those who completed 6 months of follow-up was 3.0 kg (95% CI, 2.3 to 3.8 kg) in the patch group and 2.2 kg (95% CI, 1.7 to 2.8 kg) in the placebo group (P=0.09). The combination treatment group reported more nausea, sleep disturbances, skin reactions, constipation, and depression, but only skin reactions were significantly higher (14.4% vs. 7.8%; P=0.03), including localized erythema (n=21), itch (n=6), mild generalized reactions (n=3) and worsening of preexisting acne (n=1). The placebo patch group also had localized erythema (n=11) or itch (n=2), mild generalized dermatitis (n=3), and gingivitis (n=1) and reported more abnormal dreams and headaches.

Overall, 140 (78.2%) and 137 (76.5%) participants who were randomized to receive the nicotine replacement therapy patch and who completed the treatment period (12 weeks) showed at least an 80% adherence with varenicline and the patch, respectively, compared with 139 (80.3%) and 143 (82.7%) participants randomized to receive the placebo patch.

"The additive efficacy of combining the 2 drugs is not easily explained, given that both target α4β2 nicotine receptors," the authors wrote. "It is possible that neither varenicline nor nicotine fully saturate all α4β2 nicotine receptors in the brain, leaving room for the action of the other. Alternatively, nicotine replacement may bind to different (additional) receptors involved in nicotine dependency."

ACP Internist covered ways to help smokers quit in its Internal Medicine 2014 coverage.

In other news about smoking, e-cigarettes should be restricted or banned, or at as least closely regulated as medicines or tobacco products, until more information about their safety is available, major pulmonology subspecialty societies said in a joint position paper published July 9 in the American Journal of Respiratory and Critical Care Medicine.

In addition, a July 10 health policy brief from Health Affairs and the Robert Wood Johnson Foundation described federal policymakers' recent efforts to propose rules for e-cigarettes. The brief examined the background of federal policies, critics and supporters' views of e-cigarettes, the question of e-cigarettes' safety, whether or not they should be regulated by the FDA as a tobacco product or a medical device, and an FDA-proposed rule on regulating e-cigarettes.

ACP Internist covered the e-cigarette debate in its March 2014 issue.



Test yourself


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MKSAP Quiz: 5-year history of slowly progressive dysphagia

A 25-year-old man is evaluated for a 5-year history of slowly progressive solid-food dysphagia that is accompanied by a sensation of food sticking in his lower retrosternal area. He has compensated by modifying his diet and avoiding fibrous meats. He has not lost weight, and he has not had trouble drinking liquids. He has had episodes of food impaction that he manages by inducing vomiting. He has had no difficulty initiating a swallow and has not had chest pain, odynophagia, reflux symptoms, or aspiration of food while swallowing. He has seasonal allergies that are treated with antihistamines and asthma that is treated with inhaled albuterol.

mksap.gif

Physical examination is normal.

Which of the following is the most likely diagnosis?

A: Achalasia
B: Eosinophilic esophagitis
C: Esophageal candidiasis
D: Esophageal malignancy
E: Oropharyngeal dysphagia

Click here or scroll to the bottom of the page for the answer and critique.


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Medication adherence


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Varying appearance of generic pills may affect medication adherence after MI

Adherence to medications after myocardial infarction (MI) in patients with cardiovascular disease may be affected by variation in pill appearance, according to a new study.

annals.jpg

Researchers performed cohort and nested case-control studies using claims from a U.S. commercial health insurance database to examine whether inconsistent appearance of generic medications was associated with inconsistent use in patients with cardiovascular disease after MI. Patients who were hospitalized for an MI and discharged between 2006 and 2011 and started treatment with a generic beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, angiotensin II-receptor blocker (ARB), or statin were included.

Case patients were those who stopped their index medication for at least a month, and control patients were those who continued treatment. The researchers matched control patients to case patients by therapeutic medication class, sex, age, and number of times the drug was dispensed before treatment nonpersistence. Rates of changes in pill color and shape in the year after MI were determined, and the 2 refills preceding nonpersistence were examined to see whether pill color or shape had changed. The study results appear in the July 15 Annals of Internal Medicine.

A total of 11,513 patients began treatment with a generic prescription drug in the class of interest 90 days after hospital discharge for MI. Most of the patients were men with commercial insurance; the average age was 57.7 years. A generic beta-blocker was the most common drug prescribed (75.4% of patients), followed by a generic ACE inhibitor or ARB blocker (52.8%) and a generic statin (40.0%). Change in pill shape or color affected 29% of patients (3,286 of 11,513) during the study. Statins changed appearance most often, and beta-blockers changed appearance least often. There were 4,573 episodes of treatment nonpersistence matched to 19,881 control episodes. Odds of nonpersistence in case-patients increased 34% after a pill color change (adjusted odds ratio, 1.34; 95% CI, 1.12 to 1.59) and 66% after a pill shape change (adjusted odds ratio, 1.66; 95% CI, 1.43 to 1.94).

The authors acknowledged that they examined only 3 categories of drugs prescribed after MI, that they did not evaluate effects on clinical outcomes, and that they had no data on socioeconomic status or enrollment in automatic refill programs. However, they concluded that variation in appearance of generic pills is associated with nonpersistent use after MI in patients with heart disease. "Until the FDA or manufacturers of generic drugs take the initiative to make consistent pill shape or color an industry standard, it is incumbent on prescribers and pharmacists to take steps to warn patients about the diversity of the shapes and colors of the pills containing their generic cardiovascular drugs to reduce the burden of these changes on the public health," the authors wrote.



Women's health


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Selective COX-2 inhibitors associated with slightly increased risk for adverse cardiovascular events in postmenopausal women

Postmenopausal women who used selective COX-2 inhibitors and NSAIDs with more COX-2 than COX-1 inhibition had a modestly increased risk for cardiovascular events, a study concluded.

Researchers reviewed data from the Women's Health Initiative to examine the primary outcome of total cardiovascular disease, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. A secondary analysis considered the association of selective COX-2 inhibitors, nonselective agents with relatively more COX-2 inhibition, and nonselective agents with relatively more COX-1 inhibition.

Selective COX-2 inhibitors included rofecoxib and celecoxib. Nonselective NSAIDs with relatively more COX-2 included naproxen, and nonselective NSAIDs with relatively more COX-1 inhibition included ibuprofen. Results appeared online July 8 at Circulation: Cardiovascular Quality and Outcomes.

There were 160,801 participants (1,793,222 person-years), with a mean follow-up of 11.2 years in the analysis. Among this cohort, 53,142 reported regular NSAID use at some point in time.

The primary outcome occurred in 12,733 cases, or an overall incidence rate of 71 events per 10,000 person-years.

The unadjusted hazard ratio (HR) for an event associated with any type of NSAID use was 1.16 (95% CI, 1.11 to 1.21; P<0.001), and the adjusted HR was 1.10 (95% CI, 1.06 to 1.15; P<0.001). Selective COX-2 inhibitors were associated with a modest risk for cardiovascular events (HR, 1.13; 95% CI, 1.04 to 1.23; P=0.004), as was celecoxib alone (HR, 1.13; 95% CI, 1.01 to 1.27; P=0.031).

Agents with more COX-2 inhibition than COX-1 inhibition also showed increased risk (HR, 1.17; 95% CI, 1.10 to 1.24; P<0.001), as did naproxen (HR, 1.22; 95% CI, 1.12 to 1.34; P<0.001). There was no similar risk elevation for agents with more COX-1 inhibition than COX-2 inhibition (HR, 1.01; 95% CI, 0.95 to 1.07; P=0.884) or for ibuprofen alone (HR, 1.00; 95% CI, 0.93 to 1.07; P=0.996).

The authors noted that although the risk for cardiovascular disease appeared slightly higher with nonselective NSAIDs with relatively more COX-2 than COX-1 inhibition than for COX-2 selective agents, the magnitude of risk with these 2 classes of agents was similar. However, COX-2 selective agents seemed to be associated with a greater hazard for stroke, compared to nonselective NSAIDs with relatively more COX-2 inhibition, which were associated with a greater hazard for myocardial infarction.

The authors wrote that they didn't find a higher cardiovascular risk with medications that had more COX-1 than COX-2 inhibition, which may indicate that such agents have a better cardiovascular safety profile for long-term use in postmenopausal women.



Pulmonology


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Early hospital-initiated rehab for chronic respiratory disease shows no benefit versus usual care

Patients hospitalized for chronic respiratory disease did not appear to benefit from early rehab started during their hospital stay versus usual care, according to a new study.

Researchers at 2 affiliated teaching hospitals in the United Kingdom performed a randomized, controlled trial to determine whether early rehab during acute admission for chronic respiratory disease exacerbations would improve outcomes and reduce risk for readmission. Patients with an exacerbation of chronic respiratory disease were assigned within 48 hours of hospital admission to receive early rehab or usual care. Early rehab involved a 6-week intervention that included prescribed aerobic, resistance, and neuromuscular electrical stimulation training, along with information on self-management and education. Usual care included physiotherapy (airway clearance, mobility assessment and supervision, and smoking cessation advice) and nutritional status assessment, along with outpatient pulmonary rehab offered 3 months after hospital discharge. The study's primary outcome measure was readmission rate at 12 months; secondary outcome measures were number of hospital days, mortality rate, physical performance, and health status. The study results were published online by The BMJ on July 8.

One hundred ninety-six patients were assigned to the early rehab group, and 193 were assigned to the usual care group. Mean age was approximately 71 years, and 44% and 45% of patients in each group, respectively, were men. Most of the patients (82%) had chronic obstructive pulmonary disease as their primary diagnosis. A total of 233 patients (60%) had at least 1 readmission in the year after their index admission, 62% of the early rehab group (122 of 196 patients) and 58% of the usual care group (111 of 193 patients), with no significant between-group difference (hazard ratio, 1.1; 95% CI, 0.86 to 1.43; P=0.4). Mortality rate appeared to increase in the intervention group at 1 year (odds ratio, 1.74; 95% CI, 1.05 to 2.88; P=0.03). Both groups demonstrated significant improvement in physical performance and health status after hospital discharge, and no significant between-group difference in these outcomes was noted at 1 year.

The authors noted that they included patients with various chronic respiratory diseases and that their results apply only to patients with fewer than 5 hospital admissions in the previous 12 months. However, they concluded that early rehab during hospital admission for acute exacerbation of chronic respiratory disease does not reduce readmission risk or improve physical outcomes over the next year compared with usual care. "The lack of impact on physical function and readmissions and the observation of an increased mortality at 12 months in the intervention group indicate caution before implementing such programmes during the immediate recovery from acute illness," the authors wrote.



Practice management


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Physicians and teaching hospitals begin registering in CMS's Open Payments

Physicians and teaching hospitals must register with the Open Payments system if they want the opportunity to review and dispute data submitted by applicable manufacturers and applicable group purchasing organizations (GPOs) prior to public posting on Sept. 30.

In order to review or dispute data submitted by industry for the 2013 reporting period, physicians must be registered and have reviewed any data reported about them on or before Aug. 27, 2014, the end of the initial 45-day review and dispute period. With identity verification as part of the registration process, which can take some time, CMS recommends completing the registration process as soon as possible and not waiting until the end of this initial 45-day review and dispute period. On July 22, CMS will host a National Provider Call. CMS also is developing resources to help guide industry, physicians, and teaching hospitals through the Open Payments review and dispute process. Registration for the call and the CMS resources may be found online.



From the College


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Clinicians needed for survey on patient health behaviors

ACP is making available to its members an online survey that is part of research being conducted at Baylor College of Medicine to explore the influence of behavioral counseling used by primary care practitioners with patients exhibiting risky health behaviors.

The survey will assess the current level of awareness and training among primary care practitioners in health behavioral counseling—how often it is used, obstacles to its use, and opinions about its effectiveness.

Your participation is voluntary and responses are anonymous and will not be linked to your identity or e-mail address. To participate in this 2- to 3-minute web survey, please use this link.



Cartoon caption contest


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Vote for your favorite entry

ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner.

acpi-20140715-cartoon.jpg

"So, darling, what ales you?"

"I really like this approach to introducing your new IPA to our group."

"I always like to let my alcohol breathe a little bit before I drink it."

Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting ends on Monday, July 21, with the winner announced in the July 22 issue.


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MKSAP Answer and Critique



The correct answer is B: Eosinophilic esophagitis. This item is available to MKSAP 16 subscribers as item 59 in the Gastroenterology and Hepatology section. More information is available online.

Slowly progressive solid-food dysphagia in a young man who has allergic diseases is likely due to eosinophilic esophagitis. This patient's history (location of symptoms, absence of aspiration, and intact initiation of swallows) suggests esophageal dysphagia rather than oropharyngeal dysphagia. Patients with eosinophilic esophagitis can present with symptoms similar to those of gastroesophageal reflux disease, but young adults frequently present with extreme dysphagia and food impaction. There is a strong male predominance. The diagnosis is made by endoscopy, with mucosal biopsies showing marked infiltration with eosinophils (>15 eosinophils/hpf), and the exclusion of gastroesophageal reflux by either ambulatory pH testing or by nonresponse to a therapeutic trial of proton-pump inhibitors for 6 weeks. Macroscopic findings at endoscopy are nonspecific and insensitive but proximal strictures are most consistently observed. Other findings include mucosal rings (sometimes multiple), mucosal furrowing, white specks, and mucosal friability. Some patients have evidence of a motility disorder, suggesting involvement of the muscular layers. Treatment with swallowed aerosolized topical corticosteroid preparations or systemic corticosteroids provides excellent short-term relief.

Slowly progressive solid-food dysphagia in the absence of dysphagia to liquids is more suggestive of an intraluminal mechanical cause (such as a stricture or ring) than a motility disturbance like achalasia, which usually presents with dysphagia to both solids and liquids and may be associated with chest pain and regurgitation.

Esophageal infections in immunocompetent persons are most common in patients who use swallowed aerosolized corticosteroids or in patients with disorders that cause stasis of esophageal contents. Candida albicans is the most common organism causing esophagitis in immunocompetent patients. Although esophageal candidiasis can present with dysphagia, the chronic nature of this patient's symptoms (lasting for years) and the absence of oropharyngeal candidiasis make esophageal candidiasis an unlikely cause.

Malignancy is an unlikely diagnosis because of this patient's young age, long duration of symptoms, and lack of weight loss despite prolonged symptoms.

Oropharyngeal dysphagia is characterized by difficulty in the initial phase of swallowing, in which the bolus is formed in the mouth and is transferred from the mouth through the pharynx to the esophagus. This patient is not experiencing difficulty swallowing.

Key Point

  • Slowly progressive solid-food dysphagia in a young man who has allergic diseases is likely due to eosinophilic esophagitis.

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Test yourself

A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?

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